COVIDPhase 2NCT04419025
Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease
A Phase 2 study testing N-acetylcysteine in people with COVID and Sars-CoV2, run by Cambridge Health Alliance at 4 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy of N-acetylcysteine (NAC) in preventing those with mild or moderate COVID-19 from progressing to severe disease Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID, Sars-CoV2, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
- What is being tested?
- N-acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Sep 2020to 14 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- known or suspect COVID-19 disease AND one or more of the following influenza-like symptoms, including: diarrhea vomiting fever (subjective or measured) chills myalgias fatigue sore throat headache cough nasal/sinus congestion or rhinorrhea shortness of breath chest pain
Who cannot join
- Minors, pregnant women and people unable to provide informed consent are excluded from this study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
CHA Cambridge Hospital
Cambridge, Massachusetts, 02138
CHA Everett Hospital
Everett, Massachusetts, 02149
CHA Respiratory Clinic
Somerville, Massachusetts, 02143
CHA Somerville campus
Somerville, Massachusetts, 02144
About this study
Official title: Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease
The purpose of this study is to assess the efficacy of N-acetylcysteine (NAC) in preventing those with mild or moderate COVID-19 from progressing to severe disease
Read the detailed description
After being informed of the study and potential risks and benefits, patients meeting eligibility requirements will be randomized to receive oral N-acetylcysteine (NAC) as follows:
Inpatients:
- N-acetylcystine (NAC) 25 mg/kg PO (rounded up to the nearest 600 mg) q4hrs until discharge
- N-acetylcysteine (NAC) 1200 mg PO BID x 1 week post-discharge
Outpatients:
- N-acetylcysteine (NAC) 2400 mg PO x 1 then 1200 mg PO BID x 2 weeks
- Conditions
- COVID, Sars-CoV2, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, Oxidative Stress
- Being tested
- N-acetylcysteine
- Keywords
- Glutathione, Acetylcysteine, Oxidative stress, NAC, COVID, COVID-19, SARS-CoV2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
Also called NAC, acetylcysteine, N-acetyl-L-cysteine, NALC
Oral formulation: 600 mg capsules of N-acetylcysteine
| Study group | Role | What they receive |
|---|---|---|
| NAC | Active comparator | Patients receiving N-acetylcysteine (NAC) Receives: Drug: N-acetylcysteine |
| Control | No intervention | Patients not receiving N-acetylcysteine (NAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Respiratory Rate
Decrease in dyspnea measured by respiratory rate (RR)
Measured: First hour after first dose of NAC
Hospital length of stay (LOS)
Hospital LOS for admitted patients
Measured: Through study completion, average 9 months
Need for mechanical ventilation
Whether a patient needed mechanical ventilation (intubation)
Measured: Through study completion, average 9 months
Length of time intubated
If intubated, how long needing mechanical ventilation
Measured: Through study completion, average 9 months
Need for hospitalization
Outpatients on NAC needing admission to the hospital
Measured: Through study completion, average 9 months
Recovery disposition
Whether outpatients continued to recover as outpatients; whether admitted patients were managed on medical floors or level of care increased to ICU level of care; whether patients expired
Measured: Through study completion, average 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start23 Sep 2020
- Primary completion14 May 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study. One arm is the intervention arm - those receiving N-acetylcysteine (NAC). One arm is the control group - those not receiving N-acetylcysteine (NAC).
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melisa Lai-Becker, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419025
- Sponsor's protocol ID
- CHA-IRB-1139/05/20
- Status last verified
- May 2021
- First submitted
- 3 Jun 2020
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information that underlies results in published data
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease
- ClinicalTrials.gov ID
- NCT04419025
- Acronym / sponsor ID
- CHA-IRB-1139/05/20
- Conditions
- COVID, Sars-CoV2, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, Oxidative Stress
- Keywords
- Glutathione, Acetylcysteine, Oxidative stress, NAC, COVID, COVID-19, SARS-CoV2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of N-acetylcysteine (NAC) in preventing those with mild or moderate COVID-19 from progressing to severe disease
Detailed description
After being informed of the study and potential risks and benefits, patients meeting eligibility requirements will be randomized to receive oral N-acetylcysteine (NAC) as follows:
Inpatients:
- N-acetylcystine (NAC) 25 mg/kg PO (rounded up to the nearest 600 mg) q4hrs until discharge
- N-acetylcysteine (NAC) 1200 mg PO BID x 1 week post-discharge
Outpatients:
- N-acetylcysteine (NAC) 2400 mg PO x 1 then 1200 mg PO BID x 2 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study. One arm is the intervention arm - those receiving N-acetylcysteine (NAC). One arm is the control group - those not receiving N-acetylcysteine (NAC).
| Arm | Type | Receives |
|---|---|---|
| NAC | Active comparator | Drug: N-acetylcysteinePatients receiving N-acetylcysteine (NAC) |
| Control | No intervention | –Patients not receiving N-acetylcysteine (NAC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- known or suspect COVID-19 disease AND one or more of the following influenza-like symptoms, including: diarrhea vomiting fever (subjective or measured) chills myalgias fatigue sore throat headache cough nasal/sinus congestion or rhinorrhea shortness of breath chest pain
Key exclusion criteria (1 listed)
- Minors, pregnant women and people unable to provide informed consent are excluded from this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteineAlso: NAC, acetylcysteine, N-acetyl-L-cysteine, NALCOral formulation: 600 mg capsules of N-acetylcysteine | Drug | NAC |
Primary outcome
Decrease in Respiratory Rate
Time frame: First hour after first dose of NAC
Decrease in dyspnea measured by respiratory rate (RR)
Hospital length of stay (LOS)
Time frame: Through study completion, average 9 months
Hospital LOS for admitted patients
Need for mechanical ventilation
Time frame: Through study completion, average 9 months
Whether a patient needed mechanical ventilation (intubation)
Length of time intubated
Time frame: Through study completion, average 9 months
If intubated, how long needing mechanical ventilation
Need for hospitalization
Time frame: Through study completion, average 9 months
Outpatients on NAC needing admission to the hospital
Recovery disposition
Time frame: Through study completion, average 9 months
Whether outpatients continued to recover as outpatients; whether admitted patients were managed on medical floors or level of care increased to ICU level of care; whether patients expired
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19Link provided by the sponsor.
- Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19Link provided by the sponsor.
- Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information that underlies results in published data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcysteine in people with COVID and Sars-CoV2, run by Cambridge Health Alliance at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Respiratory Rate (time frame: First hour after first dose of NAC). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.